maltitol
Result of Inspection:
Test Item | BP 98 Standard | Test Result |
Appearance | White Crystal Powder | White Crystal Powder |
Melting Point | 165-170 | 1660 C |
Loss on Drying (H2O – water) % | 0.5 | 0.23 |
Acidity or Alkalinity ml | 0.3 | 0.3 |
Clarity and Colour of Solution | No.1 turbidimetric solution | Qualified |
Sulphate % | 0.01 | 0.01 |
Oxalate % | 0.02 | 0.02 |
Residue on Ignition % | 0.1 | 0.1 |
Heavy Metals mg/kg | 10 | 10 |
Arsenic mg/kg | 2.0 | 2.0 |
Chloride | 0.005 | 0.003% |
Sulphate | 0.01 | 0.01% |
Content | 98.0-102 | 99.9% |
Total bacteria count | Max 1000CFU/g | Qualified |
Aerobic bacteria | 10 CFU/g | Qualified |
Eschericlia coli | Negative | Negative |
Salmonella | Negative | Negative |
Specific rotation | +137° to +145° | +140° |
Reducing Sugars | Qualified | Qualified |
Bacteria Endotoxins | 2.5IU/G | Negative |
Preparation | Mannitol Intravenous Infusion (Sterile) | |
SUMMING-UP | PASS USP26 |
maltitol